ASTERIX: Low Dose ASA and Nexium

March 11, 2009 updated by: AstraZeneca

A Randomized Double-Blind Placebo-Controlled Study to Assess the Prevention of Low-Dose Acetylsalicylic Acid (ASA) Associated Gastroduodenal Lesions and Upper Gastrointestinal Symptoms in Patients Taking Esomeprazole 20 mg Once Daily for 26 Weeks.

The purpose of the study is to evaluate the effect of esomeprazole 20 mg od versus placebo for the prevention of gastric and/or duodenal ulcers in patients taking low-dose ASA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

960

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Bondi Junction, New South Wales, Australia
        • Research Site
    • Queensland
      • Bracken Ridge, Queensland, Australia
        • Research Site
      • Carina Heights, Queensland, Australia
        • Research Site
    • South Australia
      • Adelaide, South Australia, Australia
        • Research Site
      • Ashford, South Australia, Australia
        • Research Site
      • Wayville, South Australia, Australia
        • Research Site
      • Woodville, South Australia, Australia
        • Research Site
    • Victoria
      • Ballarat, Victoria, Australia
        • Research Site
      • Malvern, Victoria, Australia
        • Research Site
  • Bulgaria
      • Burgas, Bulgaria
        • Research Site
      • Pleven, Bulgaria
        • Research Site
      • Russe, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada
        • Research Site
      • Carbonear, Newfoundland and Labrador, Canada
        • Research Site
      • St. John's, Newfoundland and Labrador, Canada
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada
        • Research Site
      • London, Ontario, Canada
        • Research Site
      • North York, Ontario, Canada
        • Research Site
      • Oakville, Ontario, Canada
        • Research Site
      • Sudbury, Ontario, Canada
        • Research Site
      • Thornhill, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Prince Edward Island
      • Parkdale, Prince Edward Island, Canada
        • Research Site
    • Quebec
      • Courcelette, Quebec, Canada
        • Research Site
  • Germany
      • Hamburg, Germany
        • Research Site
      • Herne, Germany
        • Research Site
      • Köln, Germany
        • Research Site
      • Künzing, Germany
        • Research Site
      • Lienen, Germany
        • Research Site
      • Ludwigshafen, Germany
        • Research Site
      • Lüdenscheid, Germany
        • Research Site
      • Münster, Germany
        • Research Site
      • Oelde, Germany
        • Research Site
      • Paderborn, Germany
        • Research Site
      • Potsdam, Germany
        • Research Site
      • Ribnitz-Damgarten, Germany
        • Research Site
      • Rostock, Germany
        • Research Site
      • Siegen, Germany
        • Research Site
      • Wangen, Germany
        • Research Site
      • Wiesbaden, Germany
        • Research Site
      • Wolfenbüttel, Germany
        • Research Site
      • Wolmirstedt, Germany
        • Research Site
      • Zeven, Germany
        • Research Site
    • Baden-Württemberg
      • Stuttgart, Baden-Württemberg, Germany
        • Research Site
    • Bayern
      • München, Bayern, Germany
        • Research Site
    • Brandenburg
      • Cottbus, Brandenburg, Germany
        • Research Site
    • Hessen
      • Frankfurt, Hessen, Germany
        • Research Site
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany
        • Research Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany
        • Research Site
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany
        • Research Site
      • Münster, Nordrhein-Westfalen, Germany
        • Research Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany
        • Research Site
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Ioannina, Greece
        • Research Site
      • Piraeus, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Eger, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Gy¿r, Hungary
        • Research Site
      • Kecskemét, Hungary
        • Research Site
      • Miskolc, Hungary
        • Research Site
      • Vác, Hungary
        • Research Site
  • Italy
      • Napoli, Italy
        • Research Site
      • Roma, Italy
        • Research Site
    • BO
      • Bologna, BO, Italy
        • Research Site
    • GE
      • Genova, GE, Italy
        • Research Site
    • PR
      • Parma, PR, Italy
        • Research Site
  • South Africa
      • Cape Town, South Africa
        • Research Site
      • Johannesurg, South Africa
        • Research Site
      • Lyttelton Manor, South Africa
        • Research Site
      • Parktown, South Africa
        • Research Site
      • Tygerberg, South Africa
        • Research Site
  • Spain
      • Granada, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Murcia, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
    • A Coruña
      • Santiago, A Coruña, Spain
        • Research Site
      • Santiago de Compostela, A Coruña, Spain
        • Research Site
    • Guipuzcoa
      • San Sebastián, Guipuzcoa, Spain
        • Research Site
  • United Kingdom
      • Edinburgh, United Kingdom
        • Research Site
    • Ayrshire
      • Irvine, Ayrshire, United Kingdom
        • Research Site
    • Scotland
      • Glasgow, Scotland, United Kingdom
        • Research Site
    • South Wales
      • Cardiff, South Wales, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A clinical diagnosis of a condition (cardiovascular and/or cerebrovascular protection or other reasons) that requires daily intake of low-dose ASA, 75-325 mg, and is expected to continue for the duration of the study (daily is defined as at least 5 days per week).
  • Age >= 60 years.
  • No gastric and/or duodenal ulcer at the baseline endoscopy.
  • H. pylori negative by serology test at screening.

Exclusion Criteria:

  • Upper GI symptoms
  • Erosive oesophagitis
  • Malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary variable is presence of gastric and/or duodenal ulcers at endoscopy over a 26-week period in patients taking low-dose ASA.

Secondary Outcome Measures

Outcome Measure
LA classification for the oesophagus at endoscopy. Upper GI symptoms assessed by the investigator at each study visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Nexium Medical Science Director, MD, AstraZeneca
  • Principal Investigator: Neville Yeomans, MD, Perth Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

November 9, 2005

First Submitted That Met QC Criteria

November 9, 2005

First Posted (Estimate)

November 11, 2005

Study Record Updates

Last Update Posted (Estimate)

March 12, 2009

Last Update Submitted That Met QC Criteria

March 11, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9617C00011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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